Mechanical Thrombectomy for Acute Pulmonary Embolism

NCT07032025 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: EARLY-MYO-PE
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research Objective: To prospectively compare the efficacy and safety of a pre-collaboratively developed ultra-thin PTFE minimally invasive thrombectomy system versus standard pharmacological therapy in patients with acute pulmonary embolism (PE), both administered on top of standard care. Research Content: Patients meeting all the following criteria will be enrolled: Aged 18-75 years (male or female) Clinically diagnosed with acute PE Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA) Provision of voluntary written informed consent. Study Design: After confirming eligibility, subjects will be randomized at a 1:1 ratio into two groups: Innovative Device Group: Minimally invasive thrombectomy Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation Study Endpoints: Primary Efficacy Endpoint: Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment. Primary Safety Endpoint: Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment, defined as: Procedure-related death Major bleeding (per VARC-2 criteria: life-threatening, disabling, or major bleeding) Treatment-related clinical deterioration, including: Unplanned mechanical ventilation Arterial hypotension (systolic blood pressure \<90 mmHg for \>1 hour or requiring vasopressors) or shock Cardiopulmonary resuscitation Sustained deterioration in oxygenation Emergency surgical embolectomy. Key Terminology Notes: RV/LV: Right Ventricular/Left Ventricular diameter ratio (standard medical abbreviation retained). VARC-2: Valve Academic Research Consortium-2 (internationally recognized bleeding criteria). PTFE: Polytetrafluoroethylene (material name preserved). MAE: Major Adverse Events (acronym defined at first use). Clinical deterioration: Explicitly specified with objective clinical indicators. This translation maintains scientific precision while adhering to international clinical trial reporting standards (ICH-GCP). The structure aligns with typical English-language study protocols for clarity and reproducibility.

Conditions

Acute Pulmonary Embolism

Keywords

Prospective Studies; Pulmonary Embolism; Thrombectomy

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

  Reduction in RV/LV ratio (measured by CTPA) from baseline to 48 hours post-treatment.

  48 hours post-treatment.

• Primary Safety Endpoint:

  Incidence of Major Adverse Events (MAEs) from baseline to 48 hours post-treatment

  48 hours post-treatment

Study Arms (2)

Innovative Device Group: Minimally invasive thrombectomy

EXPERIMENTAL

Procedure: Innovative Device Group

Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation

ACTIVE COMPARATOR

Drug: Standard Pharmacological Therapy Group

Interventions

Innovative Device Group PROCEDURE

Catheter-based thrombectomy is performed within 4 hours after baseline CTPA acquisition. Pre-procedural anticoagulation with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is administered prior to thrombectomy. Post-procedural oral anticoagulation is transitioned to rivaroxaban 20 mg once daily (QD).

Innovative Device Group: Minimally invasive thrombectomy

Standard Pharmacological Therapy Group DRUG

Following thrombolytic agent administration, anticoagulation with rivaroxaban is initiated and maintained at 15 mg twice daily (BID) for the initial 3 weeks, then switched to 20 mg once daily (QD) thereafter.

Standard Pharmacological Therapy Group: Pharmacological thrombolysis + anticoagulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years (male or female)
• Clinically diagnosed with acute PE
• Right ventricular/left ventricular diameter ratio (RV/LV) ≥0.9 on computed tomographic pulmonary angiography (CTPA)
• Provision of voluntary written informed consent.

You may not qualify if:

• Target vessel diameter \<6 mm
• Calcification, plaque, or stenosis in target lesion
• Sustained systolic blood pressure \<90 mmHg for \>15 minutes or requiring vasopressors to maintain SBP ≥90 mmHg
• Peak pulmonary artery pressure \>70 mmHg
• Hematocrit \<28%
• History of chronic pulmonary hypertension
• Pre-existing left bundle branch block
• Chronic left heart failure with left ventricular ejection fraction (LVEF) ≤30%
• Renal dysfunction (serum creatinine \>1.8 mg/dL or \>159 μmol/L)
• Known coagulopathy or bleeding diathesis:
• Platelet count \<50×10⁹/L, or International Normalized Ratio (INR) \>3
• Contraindications to antiplatelet/anticoagulant therapy
• Cardiothoracic or pulmonary surgery within 7 days prior
• Intracardiac thrombus
• Patients on extracorporeal membrane oxygenation (ECMO)

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06